Govt taps hospitals on medical devices
Currently, some of the hospitals are importing medical devices from original equipment manufacturers. As per government provisions, there is a requirement of import licence for medical devices.
New Delhi: The Central government is considering a proposal on whether the bigger hospitals like AII India Institute of Medical Sciences (AIIMS), Post Graduate Institute of Medical, Education & Research (PGIMER) Chandigarh, Medanta and Directorate General of Armed Forces Medical Services Armed Forces Hospitals (DGFAMS) should be allowed to procure or import medical devices directly from the manufacturers.
Currently, some of the hospitals are importing medical devices from original equipment manufacturers. As per government provisions, there is a requirement of import licence for medical devices. At the same time there is no provision on whether a hospital can directly procure medical devices.
Therefore, the health ministry has sought a consultation with experts from top hospitals to understand the process being followed by hospitals for procuring of medical devices.
“The Drugs Technical Advisory Board (DTAB) discussed that the hospitals like AIIMS, PGIMER, MEDANTA, DGFAMS are importing medical devices directly from Original Equipment Manufacturer (OEM) for the consumption/use at their institutes only. However, there is requirement of import licence to import the medical devices in line with provisions of Medical Devices Rules, 2017,” said one of the official on the board. Currently, there is no specific provision in the MDR, 2017 for allowing import of such equipment directly by the hospitals.
“Therefore, it was proposed to make a provision in MDR, 2017, an exemption for import of medical devices directly by the hospitals on behalf of the authorized agent, which require them to be covered by a license for import provided that the Central Licensing Authority, subject to certain conditions,” the board said.Queries sent to the health ministry did not elicit any response.
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First Published:9 Jul 2023, 09:30 PM IST
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